Medical device software requires extensive installation qualification (IQ) and operational qualification (OQ). Performing infrastructure qualification manually introduces human error and audit vulnerabilities. This guide details how Terraform, Open Policy Agent, and automated compliance engines codify FDA Part 820 regulations into GitOps pipelines.
Before any cloud infrastructure modification is deployed, OPA policies verify that unencrypted S3 buckets, permissive security groups, and unlogged IAM roles are rejected at pull request time.
Automated scripts compile system snapshots, penetration test results, and cryptographic key audits into digitally signed PDF compliance binders for annual FDA QSR inspections.